EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.

Not Applicable

Active, not recruiting

• Conditions: Acute Cholecystitis
• Interventions: Device: EUS-guided gallbladder drainage (EGBD)

• Registration Number: NCT04197908
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.

Detailed Description

The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.

The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.

Study Timeline

• Study Start: 2019-11-29
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.

Exclusion Criteria

• Pregnancy
• Patients unwilling to undergo follow-up assessments
• Patients with suspected gangrene or perforation of the gallbladder
• Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
• Patients with duodenal obstruction
• Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
• Patients with liver cirrhosis, portal hypertension and/or gastric varices
• Abnormal coagulation: international normalised ratio (INR) > 1.5 and/or platelets < 50.000/mm3
• Previous drainage of the gallbladder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-guided gallbladder drainage (EGBD)	EUS-guided gallbladder drainage (EGBD)	The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean.

Primary Outcome Measures

Name	Time	Method
Clinical success rate	30 days	Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%

Secondary Outcome Measures

Name	Time	Method
Mortality rate	3 years	Death from any cause
Technical success rate	30 days	Defined as successful placement of a metal stent between the gallbladder and the duodenum or the stomach
30-day adverse events rate	30 days	Adverse events would be graded according to the lexicon of endoscopic adverse events
Stone or polyp recurrences	3 years	An ultrasonography of the abdomen would also be arranged yearly to check for recurrence of stones or polyps.
Quality of life scores: Gastrointestinal quality of life index	3 years	Gastrointestinal quality of life index
Reintervention rate	3 years	The number of patients requiring biliary related re-interventions within 3 years.

Trial Locations

Locations (1)

Chinese University of Hong Kong; 🇨🇳 Hong Kong, Hong Kong, China